The Steno 780G Study

Steno Diabetes Center Copenhagen40 enrolled

Overview

Treatment with insulin pumps and sensor-based glucose monitoring has proven superior to other treatment methods in type 1 diabetes. Still, the majority of people treated with insulin pumps and glucose sensors still does not meet the recommended sensor-based glycaemic targets. Automated insulin delivery systems, also known as closed-loop systems, have shown to improve TIR, TAR, and TBR compared with insulin pump and CGM systems that cannot automatically dose insulin. The primary objective of the Steno 780G study is to test the effects of the MiniMed 780G system in persons with T1D treated with insulin pump and CGM/isCGM who are not meeting glycaemic targets.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Minimed 780G insulin pumpDEVICE

This will be a 14-week, open-label, randomised, parallel-group, controlled trial comparing the efficacy of an AHCL system (MiniMed 780G, Medtronic Diabetes, Northridge, CA) with usual care (i.e., a person's usual insulin pump and CGM/isCGM system). After the 14-week trial period, the control group switches to treatment with the MiniMed 780G system. The intervention group continues with the MiniMed 780G system. Both groups are monitored for another 14 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18-75 years * Type 1 diabetes ≥2 years. * HbA1c \>=58 mmol/mol * Insulin pump treatment ≥12 months * CGM or isCGM use ≥6 months * Novorapid use ≥1 week * Carbohydrate counting and use of the insulin pump bolus calculator for most snacks and meals. * Carbohydrate intake \>80 grams per day (assessed by review of intake recorded in the insulin pump during the 2 weeks prior to the screening visit) Exclusion Criteria: * Breast-feeding, pregnancy or planning to become pregnant. * Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start. * Use of hybrid closed-loop systems * Daily use of paracetamol (acetaminophen) * Alcohol or drug abuse. * Severe cardiac disease or retinopathy contraindicating HbA1c \<53 mmol/mol. * Other concomitant medical or psychological condition that according to the investigator's assessment makes the person unsuitable for study participation. * Lack of compliance with key study procedures at the discretion of the investigator. * Unacceptable adverse events at the discretion of the investigator.

Locations (1)

Steno Diabetes Center Copenhagen

Gentofte Municipality, Denmark

Outcomes

Primary Outcomes

Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14

Difference between treatment groups in change in TIR (3.9-10.0 mmol/l) from baseline to Week 14 assessed by 2 weeks of CGM data (12 AM-12 AM (wake + sleep)).